文档介绍：标准化工作室编码[XX968T-XX89628-XJ668-XT689N]
FDAQC实验室检查指南
GUIDETOINSPECTIONSOFPHARMACEUTICALQUALITYCONTROLLABORATpecializedknowledgeinsuchmatters.
Districtmanagementmakesthefinaldecisionregardingtheassignmentof
,weexpectinvestigators,analysts
andotherstoworkasteamsandtoadvisemanagementwhenadditional
expertiseisrequiredtocompleteameaningfulinspection.
Teammembersparticipatinginapre-approvalinspectionmustreadandbe
,Pre-Approval
Inspections/
reviewedpriortotheinspection;butiftheapplicationisnotavailable
fromanyothersource,thisreviewwillhavetobeconductedusingthe
company'scopyoftheapplication.
Teammembersshouldmeet,ifpossible,priortotheinspectiontodiscuss
theapproachtotheinspection,todefinetherolesoftheteammembers,and
developmentofallreportsshouldalsobeestablishedpriortothe
.
TheCenterforDrugEvaluationandResearch(CDER)mayhaveissued
deficiencyletterslistingproblemsthatthesponsormustcorrectpriorto
theapprovalofNDA/ANDA'
toreviewsuchlettersonfileatthedistrictoffice,andtheyareexpected
repliestotheseletterstoassurethatthedataareaccurateandauthentic.
Completetheinspectioneventhoughtherehasbeennoresponsetothese
lettersorwhentheresponseisjudgedinadequate.
InadditiontothegeneralapproachutilizedinadrugCGMPinspection,the
inspectionofalaboratoryrequirestheuseofobservationsofthe
laboratoryinoperationandoftherawlaboratorydatatoevaluate
compliancewithCGMP'sandtospecificallycarryoutthecommitmentsinan
laboratory,allaspectsofthelaboratoryoperationswillbeevaluated.
Laboratoryrecordsandlogsrepresentavitalsourceofinformationthat